Sintilimab for the Treatment of Locally Advanced, Metastatic, Recurrent, or Unresectable Undiffer… (NCT05017103) | Clinical Trial Compass
TerminatedPhase 2
Sintilimab for the Treatment of Locally Advanced, Metastatic, Recurrent, or Unresectable Undifferentiated Pleomorphic Sarcoma, SiARa Cancer Study
Stopped: The drug sponsor stopped supporting study.
United States6 participantsStarted 2021-07-13
Plain-language summary
This phase II trial investigates the effects of sintilimab in treating patients with undifferentiated pleomorphic sarcoma that has spread to nearby tissue or lymph nodes (locally advanced), spread to other places in the body (metastatic), come back (recurrent), or cannot be removed by surgery (unresectable). Immunotherapy with monoclonal antibodies, such as sintilimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Histopathologically confirmed unresectable, locally advanced, recurrent or metastatic UPS
* Refractory or intolerant to at least one line of systemic chemotherapy. Patient ineligible for cytotoxic chemotherapy are eligible
* Aged \>= 18
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
* Subject must be unsuitable for definitive treatment, such as definitive chemoradiotherapy and/or surgery
* Could provide archival or fresh tissues for correlative analysis
* Have at least one measurable lesion as per RECIST version (v)1.1
* Absolute neutrophil count (ANC) \>= 1.0 x 10\^9/L
* Note: Subjects cannot receive blood transfusion, erythropoietin (EPO), or granulocyte-colony stimulating factor (GSF) within 7 days prior to the blood collection
* Platelet (PLT) count \>= 75 x 10\^9/L
* Note: Subjects cannot receive blood transfusion, erythropoietin (EPO), or granulocyte-colony stimulating factor (GSF) within 7 days prior to the blood collection
* Hemoglobin (HGB) \>= 8.0 g/dL
* Note: Subjects cannot receive blood transfusion, erythropoietin (EPO), or granulocyte-colony stimulating factor (GSF) within 7 days prior to the blood collection
* Total bilirubin (TBIL) =\< 1.5 x upper limit of normal (ULN) and alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =\< 2.5 x upper limit of normal (ULN) in subjects without hepatic metastasis
* TBIL =\< 1.5 x ULN and ALT and AST =\< 5 x ULN in subjects with hepatic metastasis…